A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

Description

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels. Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).

Conditions

Healthy Volunteers

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Study Overview

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Study Details

Study overview

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels. Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).

A Phase 1, Open-Label, Within-Dose-Level Randomized Trial to Assess the Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous 20% (Human) With Recombinant Human Hyaluronidase (TAK-881) With Ramp-Up and No Ramp-Up Dosing in Healthy Adult Participants

A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Tempe

Celerion, Tempe, Arizona, United States, 85283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Men and Women between 18 and 50 years can participate.
  • 2. Must be a non-smoker, with no use of nicotine or tobacco products for at least 3 months prior to the first dosing.
  • 3. Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
  • 4. Must be medically healthy.
  • 5. Must follow protocol-specified contraception guidance.
  • 1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
  • 2. History of alcohol or drug abuse within 2 years before dosing.
  • 3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
  • 4. History or presence of thrombotic/thromboembolic events, or venous thrombosis.
  • 5. Pregnant or breastfeeding.
  • 6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
  • 7. Recently donated blood or blood products.
  • 8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
  • 9. Has taken biologic agents within 12 weeks of screening.
  • 10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
  • 11. Has received any vaccine (including live attenuated vaccines and coronavirus disease 2019 \[COVID-19\] vaccines) during the last 30 days before dosing.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2025-10-21